Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide (TCM-TMAO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03186625
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
Beijing Genomics Institute
Information provided by (Responsible Party):
Lei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary:
Recent studies highlight the participation of gut microbes in the pathogenesis of both atherosclerotic heart disease and its adverse thrombotic events. Trimethylamine N-oxide (TMAO) is a plasma metabolite shown to be formed through a metaorganismal pathway involving nutrient precursors abundant in a Western diet and the sequential action of gut microbiota. Numerous studies reveal an association between systemic TMAO levels and cardiovascular risks in a variety of stable cohorts. The purpose of this study is to evaluate the efficacy of traditional Chinese Medicine formular (Compound pseudo-ginseng granules ) on the level of TMAO for the patient with acute coronary syndrome(ACS) undergoing percutaneous coronary intervention. 80 patients with ACS would be randomly allocated into interventional group(IG) and control group(CG). The patients in the IG would be administered by oral Compound pseudo-ginseng granules (twice per day ) for 90 days and those in the CG would receive the placebo twice per day during the same period. All of subjects would be administered with standard therapy in accordance with AHA/ACC guideline for ST-elevation myocardial infarction(STEMI) and Non ST-elevation myocardial infarction(NSTEMI).The primary endpoint is the plasma level of TMAO at 90-day follow-up. The second endpoint is the level of lipid, score of The Seattle Angina, fecal DNA extraction and pyrosequencing.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Compound Panax Notoginseng Granule Drug: Placebo Granule Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide in Acute Coronary Syndromes : A Randomized Placebo Controlled Trial
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

Arm Intervention/treatment
Experimental: Compound Panax Notoginseng Granule
On the basis of the standard treatment for ACS,eligible participants are randomized to receive Compound Panax Notoginseng Granule when they enroll.
Drug: Compound Panax Notoginseng Granule

Dosage form:granule. Composition: Panax notoginseng,Codonopsis pilosula,Salvia miltiorrhiza,Pinellia ternata,Medicated Leaven,Coptis chinensis,Citrus reticulata Blanco,etc.

Frequency:two times a day, one package per time. Duration:three months.


Placebo Comparator: Placebo Granule
On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll.
Drug: Placebo Granule
Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.




Primary Outcome Measures :
  1. the plasma level of TMAO [ Time Frame: baseline ]
    Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.

  2. the plasma level of TMAO [ Time Frame: 90-days post-procedure ]
    Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.


Secondary Outcome Measures :
  1. metagenomic DNA sequencing analysis of faecal microbiome [ Time Frame: baseline ]
    high-throughput sequencing and big data analytics

  2. metagenomic DNA sequencing analysis of faecal microbiome [ Time Frame: 90-days post-procedure ]
    high-throughput sequencing and big data analytics

  3. major adverse cardiac event [ Time Frame: 90-days post-procedure ]
    frequency of the reported cardiovascular events (defined as death, non fatal myocardial infarction,target vessel revascularization and stent thrombosis )

  4. cardiac function [ Time Frame: baseline ]
    left ventricular ejection fraction(LVEF) evaluated by echo

  5. cardiac function [ Time Frame: 90-day at follow-up ]
    left ventricular ejection fraction(LVEF) evaluated by echo

  6. Seattle Angina Questionnaire score [ Time Frame: 90-days ]
    The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception).

  7. The traditional Chinese medicine syndrome scale [ Time Frame: change from baseline at 90-days ]
    The score of phlegm and of blood stasis syndromes is evaluated by Phlegm and blood stasis syndrome questionnaire.

  8. lipid metabolism [ Time Frame: change from baseline at 90-days ]
    low-density lipoprote in cholesterol in mmol/L

  9. lipid metabolism [ Time Frame: change from baseline at 90-days ]
    total cholesterol in cholesterol in mmol/L

  10. inflammatory factors [ Time Frame: change from baseline at 90-days ]
    C-reactive protein in mg/L

  11. platelet function [ Time Frame: change from Baseline at 90-days ]
    maximal aggregation rate of platelet in percent

  12. cardiac biomarkers of necrosis [ Time Frame: Change from Baseline at 5 days ]
    cardiac troponin T (cTnT) in ug/L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. acute coronary syndrome (ACS), including ST segment elevate myocardial infarction(STEMI), Non-ST-segment elevation myocardial infarction(NSTEMI) and unstable angina(UA).
  2. TCM syndrome: Intermingled Phlegm and Blood Stasis.
  3. Aged 18 to 80 years old.
  4. sign a consent form.

Exclusion Criteria:

  1. Cardiogenic shock.
  2. Serious heart failure (NYHA IV or LVEF < 40%).
  3. With severe valvular heart disease.
  4. Severe hepatic or renal insufficiency, with serum Alanine aminotransferase ( ALT) 3 times higher than normal ceiling or serum creatinine not lower than 265 μmol/L.
  5. With acute cerebrovascular disease or severe mental illness.
  6. With active bleeding or severe hematopoietic system disease.
  7. With malignant tumor or life expectancy in less than three years.
  8. Pregnancy or ready to pregnant women, nursing mothers.
  9. History of taking antibiotics within the past two months.
  10. Participating in other clinical subjects .
  11. Failure to sign a consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186625


Contacts
Layout table for location contacts
Contact: Lei Wang, Ph.D & M.D 86-20-81887233-32801 Dr.wanglei@139.com
Contact: Shuai Mao, M.D +8613724078381 maoshuaitcm@163.com

Locations
Layout table for location information
China, Guangdong
Guangdong Provincial Hospital of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Lei Wang, M.D    8620-81887233-32801    Dr.wanglei@139.com   
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Beijing Genomics Institute
Investigators
Layout table for investigator information
Study Director: Xiaoyan Li, Master Guangdong Provincial Hospital of Traditional Chinese Medicine

Layout table for additonal information
Responsible Party: Lei Wang, Associate Chief Physician, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03186625     History of Changes
Other Study ID Numbers: YN2015MS21
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine:
acute coronary syndrome
gut microbiota
Trimethylamine N-oxide
percutaneous coronary intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases